The Public Health Service,
specifically the Centers for Disease Control and Prevention (CDC), recently
announced that it is recommending the use of Rapid HIV tests. Rapid HIV
tests allow an individual to learn whether their immune system has begun
to develop antibodies to HIV on the day they are tested. In fact, the test
results may be available before the individual departs from the location
where the test was given.

As of March 1998, Murex Corporation,
in Norcross, Georgia, is the only company that has received the United
States Food and Drug Administrationís (FDA) approval to commercially manufacture
and distribute Rapid HIV tests. The productís name is Single Use Diagnostic
System for HIV-1 (SUDS). SUDS has been licensed for clinical use and can
produce results in approximately five to thirty minutes. The sensitivity
and specificity of SUDS is believed to be equivalent to existing HIV tests
that employ enzyme immunoassay (EIA). The results of the SUDS test must
be confirmed by a Western blot or immunofluorescence assay, which is standard
confirmation for HIV screening tests.

At a cost of less than $10
per testing kit, Rapid HIV tests offer the possibility of screening larger
numbers of people with a limited delay in the results. CDC officials believe
that HIV prevention programs will be able to take advantage of Rapid HIV
tests as more products are licensed and approved by FDA. Along these lines,
however, the manner and timing of HIV counseling will be significantly
altered. The CDC has identified several HIV counseling issues that will
require integration and implementation by various public and private health
care providers. In addition to counseling concerns, issues affecting program
and clinic managers include:

substantial increase in the
cost of the Rapid HIV test when compared to traditional EIA tests;

sufficiency of quality assurance
programs and proficiency testing; and

manner the test results will
be evaluated.

As Rapid HIV tests are considered
for use, and ultimately used, protection of patient confidentiality, informed
consent, and infectious disease reporting requirements will be further
complicated. Health officials are attracted to Rapid HIV tests because
many people who now take the standard EIA test do not return to find out
the results, use fictitious names, or do not avail themselves to counselors.
Products such as SUDS offer the possibility of earlier detection, which
allows for earlier and increased counseling on HIV and coping with a positive
test result.

Laboratories that perform
these tests will still be required to prove that their personnel are qualified
to administer and evaluate these tests as expected by the Clinical Laboratory
Improvement Act of 1988. Although FDA has been satisfied that SUDS meets
the requirements for biologics products, little discussion has been directed
toward implementing the use of Rapid HIV tests in state-sponsored HIV programs.
The significance of this approach to HIV testing will be determined by
how many people or programs take advantage of the technology and how effective
programs are in integrating counselors into the testing environment. With
the advent of speed comes the need to build in adequate protections for
both the recipient and analyzer of Rapid HIV tests.